Safety assessment of homeopathic medicines: The Adonis vernalis paradox and the 'analysis trap' of using different pharmacopeias.

Regulatory agencies have to ensure the end-user safety of botanically derived homeopathic medicines prepared with diluted starting materials derived even from toxic plants. In the case of plant-derived homeopathic products, assessment must consider the particular characteristics of an extract and its component molecules, even if diluted. The identification and quantification of these molecules have a crucial role in risk assessment, as it allows complete toxicological evaluation in a regulatory perspective. Different results can be achieved using different approaches and references supported by the same regulatory framework, as different methods of preparation used, assays and test analysis performed in compliance with different referent pharmacopoeias. All these facts can introduce a bias in the safety assessment and the paradoxical outcome for homeopathic Adonis vernalis underlines the need for caution. The case also demonstrates the relevance of considering the analytical method for assessment of all herbal medicinal products or herbal supplements, with the purpose of finding the total amount of toxicants as a good approach.

Current Status of Herbal Drug Standards in the Indian Pharmacopoeia.

The benefits of herbal drugs were well understood way back. They have been used for the promotion of health and medical purposes - in disease conditions. It is a conventional belief that herbal drugs have no side effects, are cheaper and locally available. Among Indian systems of medicines, herbs/herbal formulations are used to a larger extent. The quality control of the marketed herbs/herbal formulations is important for acquiring optimum therapeutic benefit as well as for expanding global outreach. Therefore, herbal drug standards are important. Reference standards, the Indian Pharmacopoeia Reference Substances especially the botanical reference substances and the phytochemical reference substances are required for comparison of quality of herbal drugs. The Indian Pharmacopoeia Commission has initiated the process of providing Indian Pharmacopoeia Reference Substances to the stakeholders. Therefore, this article provides an overview of the history and the status of herbal drug standards in the current and forthcoming issues of Indian Pharmacopoeia. In Indian Pharmacopeia, efforts have been made for the harmonization of standards with international counterparts wherever possible. Copyright © 2017 John Wiley & Sons, Ltd.

The quality of selected South African and international homoeopathic mother tinctures.

The high potential variability of chemical composition of the plant material involved in the manufacture of homoeopathic mother tinctures (a common source of homoeopathic medicines), renders both their quality control and assurance a significant challenge (Pande and Pathak, 2006). The absence of significant regulations regarding the quality of Complementary and Alternative Medicines (CAM) in South Africa contributes to this challenge (Gqaleni et al, 2007). In order to assess any quality differences between local and international manufacturers, the following homoeopathic mother tinctures, Artemisia absinthium, Rosmarinus officinalis e foliis recentibus, Salvia officinalis and Sambucus nigra, were chosen on the basis that they can be grown both locally in South Africa and internationally and are prepared according to the German Homoeopathic Pharmacopoeia (GHP), method 3a. Colour analysis was followed by thin layer chromatographic (TLC) analysis on each selected sample and relevant reference sample using both aluminum-backed TLC plates and glass-backed HPTLC plates. Photographs were taken of the resultant chromatograms, active components were identified, comparisons to the reference chromatograms were made and the overall quality of each homoeopathic mother tincture deduced. The quality of all nine of the selected samples manufactured internationally complied with the minimum quality standards set by the GHP. Five out of the six local samples complied with the minimum standards of the GHP._Notwithstanding the minimum GHP standards, the superior number of high quality international samples implies that their quality exceeded that of the locally manufactured tinctures. Greater regulation regarding the quality of these types of products has therefore been identified.

Quality criteria of homoeopathic mother tinctures: considerations regarding suitable tests for homoeopathic monographs.

Quantitative determination of markers may improve quality control of herbal homoeopathic mother tinctures. Since the activity of homoeopathic medicinal products does not depend on the specific content of such markers, appropriate substances can be selected according to analytical aspects only. We tested carbohydrates, amino acids, total polyphenols and flavonols in different mother tinctures. The results obtained with the latter two groups of substances imply that corresponding tests might be useful for inclusion into pharmacopoeial monographs.

The structure of the Organon.

The Organon of Medicine is the seminal text of Homeopathy. However, its grammar and structure make it obtuse and remote to both new students and veterans. We propose a demarcation of the Organon into sections, exposing the didactic structure of the Organon, and display this demarcation in concise graphic form. It is hoped that this representation will improve accessibility and understanding of the Organon for readers at all levels.